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HCRN GU16-260

Phase II study of front line therapy with nivolumab and salvage nivolumab + ipilimumab in patients with advanced renal cell carcinoma

Status: Closed to Accrual

This study is a prospective phase II trial of nivolumab in 120 treatment-naïve patients with clear cell renal cell carcinoma (ccRCC) and 40 treatment naïve patients with non-clear cell renal cell carcinoma (nccRCC). The primary objective is to determine the progression-free survival (PFS) rate at one year of nivolumab in patients with treatment-naïve ccRCC based on tumor PD-L1 expression.

  • Condition: Advanced renal cell carcinoma
  • Intervention:
    • Drug: Nivolumab
    • Drug: Ipilimumab
  • Phase: Phase II

For full description, see www.clinicaltrials.gov. (Study #NCT03117309).

Read a news release about this trial.

 
Abstracts/Posters/Presentations:

  • MB Atkins, O Jegede, NB Haas, DF McDermott, MA Bilen, J Hawley, JA Sosman, RS Alter, ER Plimack, MC Ornstein, ME Hurwitz, DJ Peace, S Signoretti, CJ Wu, PJ Catalano, HJ Hammers. Phase II study of nivolumab and salvage nivolumab + ipilimumab in treatment-naïve patients (pts) with advanced non-clear cell renal cell carcinoma (nccRCC) (HCRN GU16-260-Cohort B). Presented as poster discussion at the 2021 American Society of Clinical Oncology Annual Meeting. See abstract.
  • MB Atkins, O Jegede, NB Haas, DF McDermott, MA Bilen, CG Drake, JA Sosman, RS Alter, ER Plimack, BI Rini, ME Hurwitz, DJ Peace, S Signoretti, CJ Wu, PJ Catalano, HJ Hammers. Phase II study of nivolumab and salvage nivolumab + ipilimumab in treatment-naïve patients (pts) with advanced renal cell carcinoma (RCC) (HCRN GU16-260). Presented as an oral abstract at the 2020 American Society of Clinical Oncology Annual Meeting. See abstract.

Study Contact: studies@hoosiercancer.org; (317) 921-2050.